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Association of miltefosine with granulocyte and macrophage colony-stimulating factor (GM-CSF) in the treatment of cutaneous leishmaniasis in the Amazon region: A randomized and controlled trial.
- Source :
-
International journal of infectious diseases : IJID : official publication of the International Society for Infectious Diseases [Int J Infect Dis] 2021 Feb; Vol. 103, pp. 358-363. Date of Electronic Publication: 2020 Nov 27. - Publication Year :
- 2021
-
Abstract
- Objectives: To compare topical granulocyte and macrophage colony-stimulating factor (GM-CSF) and miltefosine (G + M) versus placebo and miltefosine (P + M) or parenteral meglumine antimoniate (MA) in the treatment of 150 patients with cutaneous leishmaniasis (CL) caused by Leishmania guyanensis in the Amazon.<br />Design: A randomized and double-blinded clinical trial.<br />Results: At 90 days after the initiation of therapy, the cure rates were 66%, 58%, and 52% for the groups P + M, G + M, and MA, respectively (p > 0.05). Cure rates at 180 days did not differ. Healing time was similar in the 3 groups, but faster in the MA group as compared to the G + M group (p = 0.04). Mild and transitory systemic adverse events were frequent in all groups (above 85%). Nausea (85%) and vomiting (39%) predominated in the miltefosine groups and arthralgia (51%) and myalgia (48%) in the MA group. One patient (group MA) stopped treatment after presenting with fever, exanthema, and severe arthralgia.<br />Conclusions: Miltefosine did not present a higher cure rate than MA, and the association of GM-CSF did not improve the therapeutic response. Nevertheless, because of its less toxicity, easier administration, and a similar cure rate when compared with MA, miltefosine should remain as one of the main drugs for treating CL due to L. guyanensis. (Clinicaltrials.gov Identifier NCT03023111).<br /> (Copyright © 2020 The Authors. Published by Elsevier Ltd.. All rights reserved.)
- Subjects :
- Administration, Oral
Administration, Topical
Adolescent
Adult
Antiprotozoal Agents administration & dosage
Female
Granulocyte-Macrophage Colony-Stimulating Factor administration & dosage
Humans
Macrophage Colony-Stimulating Factor administration & dosage
Macrophage Colony-Stimulating Factor therapeutic use
Male
Meglumine Antimoniate administration & dosage
Middle Aged
Phosphorylcholine administration & dosage
Phosphorylcholine therapeutic use
Young Adult
Antiprotozoal Agents therapeutic use
Granulocyte-Macrophage Colony-Stimulating Factor therapeutic use
Leishmaniasis, Cutaneous drug therapy
Meglumine Antimoniate therapeutic use
Phosphorylcholine analogs & derivatives
Subjects
Details
- Language :
- English
- ISSN :
- 1878-3511
- Volume :
- 103
- Database :
- MEDLINE
- Journal :
- International journal of infectious diseases : IJID : official publication of the International Society for Infectious Diseases
- Publication Type :
- Academic Journal
- Accession number :
- 33253864
- Full Text :
- https://doi.org/10.1016/j.ijid.2020.11.183